Nurea, a leader in AI-driven medical imaging innovation, has announced that its PRAEVAorta®2 software has received FDA 510(k) clearance, paving the way for its introduction into the U.S. healthcare market. The clearance marks a pivotal step in transforming the way physicians diagnose, monitor, and manage aortic aneurysms—a life-threatening condition that often goes undetected until it becomes critical.
The PRAEVAorta®2 platform provides vascular specialists with state-of-the-art automated tools for accurately measuring aortic diameters on both contrasted and non-contrasted CT scans. By harnessing advanced artificial intelligence, the system supports physicians in diagnosing and following up with patients more efficiently and consistently throughout the aortic aneurysm management process.
A Comprehensive Solution for Aortic Care
PRAEVAorta®2 is part of the broader PRAEVAorta® Suite, an integrated software ecosystem designed to streamline the patient care pathway. Beyond measurement automation, the suite enables the creation of patient registries to quickly identify individuals who are eligible for surgery as well as those who require ongoing surveillance. This capability ensures that no patient is lost to follow-up after intervention—an essential factor in preventing adverse outcomes associated with delayed monitoring or missed diagnoses.
By combining data automation, imaging precision, and predictive intelligence, PRAEVAorta® Suite supports healthcare teams in making timely, evidence-based decisions while freeing up valuable clinical time.
Addressing a Silent but Deadly Disease
Aortic aneurysms, often dubbed “the silent killer,” are responsible for tens of thousands of deaths every year in the United States. They represent the 10th leading cause of death among men over 55, with approximately 20% of patients remaining undiagnosed. The condition develops slowly, often without symptoms, until the aneurysm ruptures—a medical emergency with a high mortality rate.
Early detection, regular imaging, and consistent follow-up are key to preventing rupture and reducing mortality. PRAEVAorta®2 directly supports these objectives by offering automated, reproducible measurements that improve diagnostic accuracy and enable consistent monitoring over time.
Economic and Clinical Impact
Beyond clinical benefits, PRAEVAorta® Suite also addresses the economic burden associated with abdominal aortic aneurysm (AAA) management. The software has the potential to reduce the $1.5 billion annual U.S. screening cost by half by facilitating incidental detection of aneurysms on both contrasted and non-contrasted CT scans—without the need for additional imaging procedures.
Because it integrates seamlessly into existing hospital and imaging workflows, PRAEVAorta®2 can be adopted with minimal disruption, enhancing efficiency and cost-effectiveness across vascular and radiology departments.
By enabling a more proactive and data-driven approach to patient care, PRAEVAorta® Suite supports health systems in optimizing resource allocation, reducing redundant imaging, and improving long-term patient outcomes.
A Major Milestone for Nurea
“This milestone is the result of years of research, development, and collaboration,” said Florian Bernard, CEO and co-founder of Nurea. “FDA clearance validates our vision and allows us to bring PRAEVAorta®2 to U.S. physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs, and most importantly, save lives.”
The approval underscores Nurea’s commitment to advancing AI-assisted vascular care and aligns with its broader mission to make advanced medical imaging more accessible, precise, and impactful.
Regulatory Status
PRAEVAorta®2 is classified as a Class IIb medical device and carries both CE marking (2797) for use in Europe and FDA 510(k) clearance for distribution in the United States. As with all regulated medical devices, Nurea advises users to review the instructions carefully before use to ensure proper operation and accurate results.
With FDA approval, Nurea’s PRAEVAorta®2 now stands poised to reshape the standard of care for aortic aneurysm management—bringing together cutting-edge AI technology, clinical reliability, and patient safety to address one of cardiovascular medicine’s most urgent challenges.
